Clinical Trials Directory

Trials / Completed

CompletedNCT05877261

Cementless Triathlon 5YR Follow-Up

5 Year Follow-Up of Migration of a Cementless Total Knee Replacement

Status
Completed
Phase
Study type
Observational
Enrollment
18 (actual)
Sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Academic / Other
Sex
All
Age
21 Years – 90 Years
Healthy volunteers
Not accepted

Summary

All artificial joint implants need to be solidly held (fixed) within the bone. Cementless fixation has become a popular method to achieve fixation for total knee replacements where the bone grows directly onto the implanted device instead of using bone cement. The primary purpose of this study is to assess long-term implant survivorship and clinical outcomes of a previous study cohort that received a cementless knee replacement. As this study cohort approaches 5 years post-operation, the investigators will re-examine the stability of participant implants using specialized x-rays, called "radiostereometric analysis". The study will use weight-bearing computed tomography (CT) to measure bone density and texture features and correlate that with implant stability. The investigators will collect stool samples to assess participant gut microbiomes for biomarkers of poor bone quality that could correlate to implant stability. All 33 participants from the original study cohort will be invited to participate in this study.

Conditions

Interventions

TypeNameDescription
DEVICECementless Total Knee ReplacementArtificial knee implant inserted by cementless fixation.

Timeline

Start date
2023-05-25
Primary completion
2024-04-01
Completion
2024-12-31
First posted
2023-05-26
Last updated
2025-03-17

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT05877261. Inclusion in this directory is not an endorsement.